Patient-Reported Treatment Experience with Oral Rivaroxaban: Results from the Noninterventional XALIA Study of Deep-Vein Thrombosis

Stefan Cano; Lorenzo Mantovani; Kerstin Folkerts; Martin Gebel; Kurtulus Sahin; Elizabeth Zell; Danja Monje; Jonas Schneider; Martin van Eickels; Sylvia Haas; Reinhold Kreutz; Walter Ageno; Alexander G. G. Turpie

doi:10.1055/s-0038-1641679

TH Open, Table of Contents

CC BY 4.0 · TH Open 2018; 02(02): e139-e146
DOI: 10.1055/s-0038-1641679

Original Article

Georg Thieme Verlag KG Stuttgart · New York

Patient-Reported Treatment Experience with Oral Rivaroxaban: Results from the Noninterventional XALIA Study of Deep-Vein Thrombosis

Stefan Cano

¹Modus Outcomes, Letchworth Garden City, United Kingdom

,

Lorenzo Mantovani

²CESP-Center for Public Health Research, University of Milan Bicocca, Monza, Italy

,

Kerstin Folkerts

³Bayer AG, Wuppertal, Germany

,

Martin Gebel

³Bayer AG, Wuppertal, Germany

,

Kurtulus Sahin

⁴ClinStat GmbH, Cologne, Germany

,

Elizabeth Zell

⁵Stat-Epi Associates, Inc., Ponte Vedra Beach, Florida, United States

,

Danja Monje

⁶Bayer AG, Berlin, Germany

,

Jonas Schneider

⁶Bayer AG, Berlin, Germany

,

Martin van Eickels

⁶Bayer AG, Berlin, Germany

,

Sylvia Haas

⁷Vascular Centre, Munich, Germany

,

Reinhold Kreutz

⁸Institute of Clinical Pharmacology and Toxicology, Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany

,

Walter Ageno

⁹Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy

,

Alexander G. G. Turpie

¹⁰Department of Medicine, Hamilton Health Sciences, Hamilton, Ontario, Canada

› Author Affiliations

Abstract

For venous thromboembolism (VTE) treatment, patient satisfaction was shown to improve with rivaroxaban versus standard anticoagulation in the phase III EINSTEIN DVT and EINSTEIN PE trials. This substudy of the prospective, noninterventional XALIA study of rivaroxaban for deep-vein thrombosis treatment assessed if this was also observed in routine clinical practice. Patients enrolled in XALIA who received rivaroxaban or standard anticoagulation treatment were eligible for inclusion in this substudy. Treatment decisions were at the physician's discretion. Patients completed the 17-item Anti-Clot Treatment Scale (ACTS, comprising a 12-item Burdens subscale, a 3-item Benefits subscale and one global item per subscale) during follow-up. The propensity score-matched set (PMS) was used for the main analysis; the adjusted safety analysis (ASAF) set was used for confirmatory purposes. Analyses by follow-up visit and subgroup, including age, sex, and previous VTE, were also conducted. The PMS-ACTS analysis included 458 rivaroxaban-treated and 434 standard anticoagulation-treated patients. Baseline demographic and clinical characteristics were generally similar across treatment arms. ACTS Burdens scores significantly improved with rivaroxaban versus standard anticoagulation (least-squares mean difference of 2.4 ± 0.4 points; p < 0.0001); ACTS Benefits scores were numerically higher with rivaroxaban (least-squares mean difference of 0.2 ± 0.1 points; p = 0.2). Similar findings occurred across follow-up visits and subgroups. Results were confirmed in the ASAF-ACTS analysis. Consistent with phase III analyses, rivaroxaban was associated with improved ACTS Burdens scores; ACTS Benefits scores numerically favored rivaroxaban, although without reaching statistical significance.

Keywords

ACTS - anticoagulation - patient experience - rivaroxaban - venous thromboembolism

Full Text

References

References
1 Mengiardi S, Tsakiris DA, Lampert ML, Hersberger KE. Drug use problems with self-injected low-molecular-weight heparins in primary care. Eur J Clin Pharmacol 2011; 67 (02) 109-120
2 Hamilton JG. Needle phobia: a neglected diagnosis. J Fam Pract 1995; 41 (02) 169-175
3 Erkens PM, ten Cate H, Büller HR, Prins MH. Benchmark for time in therapeutic range in venous thromboembolism: a systematic review and meta-analysis. PLoS One 2012; 7 (09) e42269
4 Wells PS, Holbrook AM, Crowther NR, Hirsh J. Interactions of warfarin with drugs and food. Ann Intern Med 1994; 121 (09) 676-683
5 Osterberg L, Blaschke T. Adherence to medication. N Engl J Med 2005; 353 (05) 487-497
6 Barbosa CD, Balp MM, Kulich K, Germain N, Rofail D. A literature review to explore the link between treatment satisfaction and adherence, compliance, and persistence. Patient Prefer Adherence 2012; 6: 39-48
7 Bauersachs R, Berkowitz SD, Brenner B. , et al; EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363 (26) 2499-2510
8 Büller HR, Prins MH, Lensin AW. , et al; EINSTEIN–PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012; 366 (14) 1287-1297
9 Bamber L, Wang MY, Prins MH. , et al. Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of acute symptomatic deep-vein thrombosis. Thromb Haemost 2013; 110 (04) 732-741
10 Prins MH, Bamber L, Cano SJ. , et al. Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of pulmonary embolism; results from the EINSTEIN PE trial. Thromb Res 2015; 135 (02) 281-288
11 Ageno W, Mantovani LG, Haas S. , et al. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study. Lancet Haematol 2016; 3 (01) e12-e21
12 Dahabreh IJ, Sheldrick RC, Paulus JK. , et al. Do observational studies using propensity score methods agree with randomized trials? A systematic comparison of studies on acute coronary syndromes. Eur Heart J 2012; 33 (15) 1893-1901
13 Collins GS, Le Manach Y. Comparing treatment effects between propensity scores and randomized controlled trials: improving conduct and reporting. Eur Heart J 2012; 33 (15) 1867-1869
14 Parsons LS. Performing a 1:N case-control match on propensity score. SAS Users Group International. Montreal, Canada, May 9–12, 2004, Poster 165–29. Available at: http://www2.sas.com/proceedings/sugi29/165-29.pdf . Accessed April 24, 2017
15 Cano SJ, Lamping DL, Bamber L, Smith S. The Anti-Clot Treatment Scale (ACTS) in clinical trials: cross-cultural validation in venous thromboembolism patients. Health Qual Life Outcomes 2012; 10: 120
16 Atkinson MJ, Kumar R, Cappelleri JC, Hass SL. Hierarchical construct validity of the treatment satisfaction questionnaire for medication (TSQM version II) among outpatient pharmacy consumers. Value Health 2005; 8 (Suppl. 01) S9-S24
17 Patrick DL, Deyo RA. Generic and disease-specific measures in assessing health status and quality of life. Med Care 1989; 27 (3, Suppl): S217-S232

Supplementary Material

Supplementary Material